Our research experience
With 70 years of Regulatory, R&D and Medical experience in the pharmaceutical sector, Angelini Pharma has successfully completed the full development of several drugs. Two of these, the topical anti-inflammatory benzydamine and the anti-depressant trazodone, are used worldwide and marketed in more than 60 countries. In the 1990s, Angelini in-licensed the fluoroquinolone antibiotic prulifloxacin, completing its preclinical and clinical development in Europe, registering it and marketing it in several countries. In the last years, Angelini Pharma further diversified the product portfolio by in-licensing the semi-synthetic antibiotic dalbavancin, a second-generation lipoglycopeptide indicated for acute bacterial skin and skin structure infections, a new prolonged-release formulation of lithium sulphate for bipolar disorder, the new antipsychotic lurasidone, indicated for the treatment of schizophrenia, and a combination of paracetamol and ibuprofen, the first in Europe and currently in clinical trials. The commitment in rare disease has been accomplished by the very recent agreement for the development, manufacturing, and commercialization in European countries of gaboxadol, an investigational drug currently in Phase III clinical development for the treatment of Angelman disease.
At present, Angelini is running above 30 clinical studies, involving over 2,000 patients in a more than a dozen countries, spanning all the clinical development phases.
Angelini is a modern group, sensitive to changes in the market and projected into the future, as demonstrated by the implementation of the innovative activities in Regulatory, Research & Development and Medical (RR&D). Indeed, the RR&D Team is highly committed to innovation and sustainability, helping to build up Angelini's portfolio in the short, medium and long term through focus, recognition and awareness.
The team helps to define the company's strategy for optimal analysis and problem solving, guaranteeing the effective management of product life cycles. RR&D is responsible for tight quality control and ethical standards, and contributes to innovation with scientific research, clinical and pre-clinical development, and registration of new pharmaceutical products in the therapeutic areas of interest. RR&D functions are organised in line with the Company strategy, working on product development from the earliest to the most advanced stages. In its way, the activity centralised and harmonised in all Angelini countries for product registration, pharmacovigilance procedures and regulatory compliance.
RR&D Projects include activities to support the life cycle management of existing products and develop new non-pharma products, usually requiring limited time to reach the market, as well as activities intended to develop innovative new pharma products in the core therapeutic areas and in new sectors.
RR&D has all the skills and expertise required for the full development of a drug, from the identification of new bioactive compounds using computational chemistry techniques and pharmacology, to chemical scale up and analytical development, bioanalysis and pharmacokinetics, formulation and clinical development, up to regulatory affairs and pharmacovigilance.
RR&D strongly believes that scientific networking is essential to innovation and has created a specific research and innovation model based on the Dynamic Pipeline concept. In this model, projects can stem from either internal activities or from leading public and private research scientists, following development in-house or with our partners, according to sustainability and opportunities.
Innovation is achieved through a dynamic scientific network aimed at cooperation and partnerships, also in the context of national and international funded programs. To this end, the Team is dedicated to identify high-profile research groups to establish public-private partnerships cooperating on internal research and on innovative products in the early stages of development.
The core therapeutic areas raised from Angelini strategic perspective valorizing the current portfolio and capabilities in alignment with our mission.
In the areas of therapeutic interventions, products are not limited to small molecules, and research and development is open to other solutions including advanced therapeutics. The innovation model is also implemented to support products already in the company's portfolio. RR&D Angelini cares about ethics andquality of the products, either pharmaceutical or non-pharmaceuticals, thus guaranteeing a high scientific level of non-clinical and clinical studies.
The areas of therapeutic intervention are linked to the wider concept of patient care. Beyond the fundamental research on molecular appropriate targets relevant to certain diseases, Angelini strives to improve patients management through non-pharmacological interventions and medical devices, to better tailor the therapeutic approach to patients needs.
Mental health, particularly mood disorders, is a field where Angelini has achieved its greatest success and recognition worldwide.
The introduction of trazodone for the treatment of major depression, during the ‘70s in Europe and in the USA in 1981, has changed the therapeutic approach to the disease. Trazodone is still used today, thanks to its broad spectrum of neuropharmacological activities and good tolerability.
Even now, RR&D is studying the mechanism of action of trazodone and new chemical entities that shown action on a variety of molecular targets in neuropsychiatric diseases, developing considerable expertise in the biochemistry and pharmacology of the neural mechanisms involved in major depression and other mood disorders. These studies are focused on the mechanisms responsible for antidepressant action following the effects on neurotransmission.
Angelini in-licensed a prolonged-release lithium formulation, the first in Italy, with proven efficacy as mood stabilizer for the treatment of bipolar disorder. More recently, a product containing lurasidone was licensed-in, extending the Company’s portfolio to the treatment of schizophrenia.
Angelini Clinical Research is continuously generating data to strengthen and deepen the scientific knowhow on the current portfolio, meanwhilethe R&D is investingating new molecular targets that are responsible for highly disabling pathologies of the nervous system, including rare diseases.
Pain & Inflammation
Angelini RR&D has a long tradition in pain and inflammation, acquiring and strengthening its core capabilities in the role of prostaglandins, cytokines, opioid and serotoninergic transmission routes in modulation of pain and inflammation.
Currently, RR&D research focuses on both new products and well-known molecules, to be used in monotherapy or in combination, with the aim to increase efficacy and reduce side effects. Moreover, formulations to optimize drug bioavailability and dose regimen are currently under investigation.
RR&D is currently conducting post-marketing clinical studies and managing the life cycle of products in the portfolio to optimise the correct and effective use in current indications.
Angelini is committed to child healthcare, developing drugs and by networking with a broad spectrum of professionals and institutions. RR&D is cooperating with leading research networks and working groups, among which the INCIPIT network of Italian paediatric centres and the ECNP on child and adolescent psychiatry, to develop and deliver cutting-edge methodologies and treatments.
The paediatric population is heterogenous, ranging from newborns to adolescents with large differences between developmental stages. This means drugs must be formulated to suit childrens age, growth stages physiological condition and treatment specific needs, with customised forms and strengths as well as routes of administration and acceptability.
The RR&D is constantly working to identify and develop innovative nutraceutical, disinfectant and biocide products, and medical devices to support pharmaceutical portfolio and company brands.
|Paracetamol new formulations|
|Ibuprofen + paracet
|New Delivery Platforms||Fentanyl|
|Kv7||Trazodone non oral||Trazodone
|GSK-3beta||Paracetamol PDA||Trazodone new
|PHASE I||PHASE II||PHASE III
Life cycle Management